N/A
N=30
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Native and Valve in Valve Aortic Valve Failure
Bottom Line
View on ClinicalTrials.gov: NCT03381989 ↗Enrolled (actual)
30
Serious AEs
43.3%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory — 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ASHI_INTECC Astato XS 20 0.014 guidewire (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory |
28 | — |
| PRIMARY Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE) |
21 | — |
Summary
Background:
TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue outward. Researchers want to study a method that may make TAVR safer. It is known as Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA).
Objective:
To study the feasibility and safety of BASILICA in people at high risk of coronary artery obstruction that complicates TAVR.
Eligibility:
People at least 21 years old whose heart doctors do not think they can have TAVR safely
Design:
Participants will be screened by a team of heart specialists. They will have heart and blood tests. They will answer questions.
Participants will have TAVR using BASILICA.
They will get general anesthesia or they will be sedated.
While using x-rays and echocardiography, doctors will cross and split the aortic valve leaflet using an electrified wire.
A standard TAVR valve will be implanted.
After the procedure, participants will have blood tests and physical exams. They will answer questions. They will have heart tests.
Participants will have a scan within 1 month and after 12 months. They will have heart tests during follow-up visits in the first year.
Sponsoring Institute: National Heart, Lung and Blood Institute
Eligibility Criteria
- INCLUSION CRITERIA:
- Adults age greater than or equal to 21 years
- High or extreme risk of surgical aortic valve replacement according to the local multidisciplinary heart team
- Undergoing TAVR for valve-in-valve or native aortic valve failure ( on-label TAVR)
- Deemed likely to suffer coronary artery obstruction from TAVR according to multidisciplinary heart team
- Concurrence of the study eligibility committee
EXCLUSION CRITERIA
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Excessive target aortic leaflet calcification or masses on baseline CT
- Survival despite successful procedure expected < 12 months
- Planned concurrent valve intervention in the same setting (such as transcatheter mitral valve therapy or paravalvular leak therapy)
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Data sourced from ClinicalTrials.gov (NCT03381989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.